Document N286vj8xVOprLVE36OoxJaMYE

Page 20 November 23, 1970 FOOD CHEMICAL NEWS They are merely private scientific exports whose opfhions form the factual basis for the agency's decision." Meanwhile, BVM's newly created Division of Nutritional Sciences (See TOOD CHEMICAL NEWS, Nov. 9, Page 20) has begun as its first major project an efficacy review of low-level antibiotic combinations used for growth promotion that were not studied by the NAS-NRC panels. FDA has been following a policy of requiring that effectiveness of each ingredient in combinations be established before granting new approvals, and has applied the same criteria to fixed combinations evaluated by the NAS-NRC (See FOOD CHEMICAL NEWS, April 6, Page 8). The new review will probably result in requests to manufacturers to supply data for previously approved combinations showing that each of the antibiotics used has an additive effect. FDA has already asked for this type of Information from producers of fixed combinations that have been reviewed by the NAS-NRC panels. Antibiotics will also be the subject of letters to manufacturers advising them that TDA does not have sufficient information on their use in liquid supplements. FDA has made a wide appeal to diethylstilbestrol producers and distributors to submit data showing that DES will be stable in liquid supplements under adverse conditions along with a request for submission of analytical methods for assaying DES liquid feed supplements and other data on safety and efficacy (See FOOD CHEMICAL NEWS, Nov. 9, Page 20). A second letter has gone to DES producers who haven't responded advising them that if the Information Isn't received within 60 days, FDA will have "to consider discontinuance of Form 1800's for medicated liquid feed supplements manufactured with your DES premix. " This same approach will be taken with the liquid antibiotics -- first a request for information followed by a warning that the Forms 1800 will be discontinued unless the requested safety and efficacy data fare submitted. O MUD ORDERS PCB'S OUT OF PESTICIDES'IN 6 MONTHS \ The Department of Agriculture's Pesticides Regulation Division has ordered poly,-chlorinated biphenyls and polychlorinated terphenyls out of pesticide formu) at ionsJ `either as active or inactive ingredients within six months. The Food and Drug Administration recently ordered a study by its field offices to determine the extent of PCB contamination of food products (See story, Page S). The PRD notice P-rt. 29 pointed, to the accumulating data-on the chronic,toxicity of the chemicals Id lish and birds and the potential contamination of the environ ment as, the tatuuin lor. the phoning out ul their use in e"-ni..mu poisons, chief of which has been e extenders to prolong the persistence of pesticides. MONS 033690 November 23, 1970 Page 21 FOOD CHEMICAL NEWS "Although the use of these chemicals in economic poisons is not considered an 5 acute hazard to man or his environment," PRD said, "they do contribute to environ- " mental pollution," adding: "Any benefits derived from their use are outweighed by the resulting environmental contamination and the possible long range adverse effects on fish and wildlife. Therefore, the presence of these chemicals in economic poisons must be phased out." PRD said it believed that six months is a reasonable period of time within which formula changes could be made, and requested copies of the revised statement of composition of new formulas plus new labeling for the affected products. PRD also corrected an earlier notice in which it said it "erroneously listed" piperonyl butoxide in a group of compounds requiring teratogenic studies (See FOOD CHEMICAL NEWS, April 27, Page 6). This compound is one that requires further carcinogenic data, PRD said, "in order to properly evaluate its safety in view of current infor mation. " In the earlier announcement, PRD listed a number of pesticides requiring teratogenic or carcinogenic testing to continue current registrations. Meanwhile, Chairman Randolph (D-W. Va.) of the Senate Public Works Committee announced last week that his Committee would begin hearings Dec. 1 on the nomina tion of William D. Ruckelshaus, former Assistant Attorney General, as Administrator of the Environmental Protection Agency (See FOOD CHEMICAL NEWS, Nov. 9, Page 37). Randolph disclosed that his Committee had jurisdiction after conferences with Chairman Magnuson (D-Wash.) of the Commerce Committee and Chairman Jackson (D-Wash.) of the Interior Committee. Randolph Invited the chairmen and the ranking minority members of those two committees plus the leaders from the Agri culture and Labor and Public Welfare Committees to sit in on the Ruckelshaus nomination.!hearings. - O SENATE UNIT MOVES CPA TOWARD ENACTMENT The Democratic leadership in Congress is hoping to move legislation to establish a new independent Consumer Protection Agency through both chambers by the first week of December. The Senate Commerce Committee Nov. 19 ordered Sen. Ribicoff's (D-Conn.) bill (S 4459) to the floor with minor modifications, which appear acceptable to the Govemmentr Operations Committee where the proposal originated (See FOOD CHEMICAL NEWS, Oot. 5, Page IS). MONS 033691 Pag* 20 November 73, 1970 FOOD CHEMICAL NEWS They are merely private scientific experts whose opinions form the factual basis for the agency's decision." Meanwhile, BVM's newly created Division of Nutritional Sciences (See FOOD CHEMICAL NEWS, Nov. 9, Page 20) has begun as its first major project an efficacy review of low-level antibiotic combinations used for growth promotion that were not studied by the NAS-NRC panels. FDA has been following a policy of requiring that effectiveness of each ingredient in combinations be established before granting new approvals, and has applied the same criteria to fixed combinations evaluated by the NAS-NRC (See FOOD CHEMICAL NEWS, April 6, Page 8). The new review will probably result In requests to manufacturers to supply data for previously approved combinations showing that each of the antibiotics used has an additive effect. FDA has already asked for this type of information from producers of fixed combinations that have been reviewed by the NAS-NRC panels. Antibiotics will also be the subject of letters to manufacturers advising them that FDA does not have sufficient Information on their use in liquid supplements. FDA has made a wide appeal to dlethylstllbestrol producers and distributors to submit data showing that DES will be stable In liquid supplements under adverse conditions along with a request for submission of analytical methods for assaying DES liquid feed supplements and other data on safety and efficacy (See FOOD CHEMICAL NEWS, Nov. 9, Page 20). A second letter has gone to DES producers who haven't responded advising them that if the information isn't received within 60 days, FDA will have "to consider discontinuance of Form 1800's for medicated liquid feed supplements manufactured with your DES premix. " This same approach will be taken with the liquid antibiotics -- first a request for information followed by a warning that the Forms 1800 will be discontinued unless the requested safety and efficacy data 'are submitted. fPRP ORDEKS PCB'S OUT OF PESTICIDES'IN 6 MONTHS } The Department of Agriculture's Pesticides Regulation Division has ordered poly chlorinated biphenyls and polychlorinated terphenvls out of pesticide formulations' `either as active or Inactive ingredients within six months. The Food and Drug Administration recently ordered a study by its field offices to determine the extent of PCB contamination of food products (See story. Page S). The PRD notice Oct. 29 pointed to the accumulating data on the chronid toxlcity of the chemicals 10 tish and birds and the potential contamination of the environ ment as the reason for the phasing out oi their use in er'.mnnic poisons, chief of which has been as extenders to prolong the persistence of pesticides. HONS 033692 November 23, 1970 Page 21 FOOD CHEMICAL NEWS "Although the use of these chemicals in economic poisons is not considered an ,~ acute hazard to man or his environment," PRD said, "they do contribute to environ- !' mental pollution," adding: \ "Any benefits derived from their use are outweighed by the resulting environmental contamination and the possible long range adverse effects on fish and wildlife. Therefore, the presence of these chemicals in economic poisons must be phased out." PRD said it believed that six months is a reasonable period of time within which formula changes could be made, and requested copies of the revised statement of composition of new formulas plus new labeling for the affected products. PRD also corrected an earlier notice in which it said it "erroneously listed" piperonyl butoxide in a group of compounds requiring teratogenic studies (See FOOD CHEMICAL NEWS, April 27, Page 6). This compound is one that requires further carcinogenic data, PRD said, "in order to properly evaluate its safety in view of current infor mation. " In the earlier announcement, PRD listed a number of pesticides requiring teratogenic or carcinogenic testing to continue current registrations. Meanwhile, Chairman Randolph (D-W. Va.) of the Senate Public Works Committee announced last week that his Committee would begin hearings Dec. 1 on the nomina tion of William D. Ruckelshaus, former Assistant Attorney General, as Administrator of the Environmental Protection Agency (See FOOD CHEMICAL NEWS, Nov. 9, Page 37). Randolph disclosed that his Committee had jurisdiction after conferences with Chairman Magnuson (D-Wash.) of the Commerce Committee and Chairman Jackson (D- Wash.) of the Interior Committee. Randolph invited the chairmen and the ranking minority members of those two committees plus the leaders from the Agri culture and Labor and Public Welfare Committees to sit in on the Ruckelshaus nomination.! hearings. - O SENATE UNIT MOVES CPA TOWARD ENACTMENT The Democratic leadership in Congress is hoping to move legislation to establish a new Independent Consumer Protection Agency through both chambers by the first week of December. The Senate Commerce Committee Nov. 19 ordered Sen. Riblcoff's (D-Conn.) bill (S 4459) to the floor with minor modifications, which appear acceptable to the Government Operations Committee where the proposal originated (See FOOD CHEMICAL NEWS, Oct. 5, Page 16). HONS 033693